To: Independent Health Facilities

Published by: Health Services Branch

Date Issued: March 22, 2017

Bulletin Number: 2122

Re: IMPAX PACS Software (Version 6.5/6.6.1/6.5.x) Issue

Posted Electronically Only

If you are a customer of Agfa Healthcare that uses any of the above noted versions of its IMPAX PACS software, you should be aware of an urgent field safety notice that was issued to all affected customers on January 25, 2017.

IHFs utilizing Agfa Healthcare IMPAX PACS Version 6.5.5 (all SUs), Version 6.6.1 (up through and including SU07), and/or Version 6.5.x, may wish to consider the following steps:

Contact Agfa Healthcare (contact information provided below) for further clarification on how the behaviour may impact radiology workflows; and

Obtain input from your insurer and legal counsel on whether a retrospective review of radiology reports is appropriate in your circumstances.

At this time, we are not aware of any patient safety incidents as a result of this software issue. Nonetheless, we would encourage licensees and/or quality advisors to take necessary steps to ensure patient safety.

For a detailed explanation, please see the Health Canada alert online at http://publicaffairs.cmail20.com/t/d-l-hyfird-tuyhjykhr-j/. Should you require more specific information, please contact your local Agfa Healthcare organization by phone: 1-877-777-2432 and reference IMPAX PACS Version 6.5.5 (all SUs) and Version 6.6.1 (up through and including SU07).

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